A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
18 Years
N/A
Both
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome, Bone Marrow Diseases, Hematologic Diseases
Trial Information
A Phase 3 Multinational, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Ph+ CML Patients in Early Chronic Phase
Inclusion Criteria:
- Patients with confirmed diagnosis of chronic phase CML within last 3 months
- Patients with cytogenetically confirmed Ph positive CML in early chronic phase
Exclusion Criteria:
- Patients with Philadelphia chromosome negative but BCR-ABL positive CML
- Patients who used imatinib for 8 days or longer before study entry
- Patients who had been treated with other targeted anti-cancer therapy, except for
Hydrea or Agrylin, which inhibits the growth of leukemic cells
- Patients with impaired cardiac function
- Cytologically confirmed CNS involvement
- Severe or uncontrolled chronic medical condition
- Other significant congenital or acquired bleeding disorders that are not related to
underlying leukemia
- Patients who had a major surgery within 4 weeks prior to study entry or has not
recovered from side effects of such surgery
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of Major Molecular Response(MMR) by 12 months
Outcome Description:
Rate of Major Molecular Response (MMR) at Any Time within 12 months. MMR by 12 months will be assessed as responder if the patient has response at any time within 12 months. A major molecular response rate is defined as the ratio (%) of BCR-ABL/ABL ≤ 0.1% by international scale or a 3-log reduction in BCR-ABL transcript level from standardized baseline, as measured by standardized RQ-PCR assay.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
IL-YANG PHARM
Investigator Role:
Study Director
Investigator Affiliation:
IL-YANG Pharmaceutical. Co., LTD
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
IY5511A3001
NCT ID:
NCT01511289
Start Date:
August 2011
Completion Date:
November 2014
Related Keywords:
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
- Bone Marrow Diseases
- Hematologic Diseases
- Radotinib
- CML-CP
- Chronic Myeloid Leukemia, chronic phase
- Bone Marrow Diseases
- Hematologic Diseases
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
Name | Location |
|---|
